Chest PainPhase 3NCT00251901
Chest Pain Pilot Study
A Phase 3 study testing Esomeprazole in people with Chest Pain and Gastroesophageal Reflux, run by AstraZeneca at 80 sites in 6 countries.
Trial summary
The purpose of this study is to compare the efficacy of Nexium® with placebo in relief of acid related pain or discomfort in the chest. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chest Pain, Gastroesophageal Reflux
- What is being tested?
- Esomeprazole
- How many people
- 600 participants
- Where
- 80 sitesin 6 countries
- Study dates
- May 2004to Jul 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain or discomfort in the chest without any identifiable cause and severe enough for the patient to seek primary medical or similar care.
- History of pain or discomfort in the chest for at least the last two weeks prior to enrollment.
Who cannot join
- Signs, symptoms or relevant investigations suggestion present symptomatic coronary heart disease.
- Patients whose pain or discomfort in the chest warrants urgent cardiac investigation.
Trial locations and contacts
80 sites in 6 countries.
80 sites in 6 countries
Germany22 sites
Research Site
Augsburg, Bavaria
Research Site
Augsburg
Research Site
Bad Segeberg, Schleswig-Holstein
Research Site
Bad Segeberg
Research Site
Berlin, State of Berlin
Research Site
Berlin
Research Site
Chemnitz
Research Site
Dillingen
Research Site
Dresden, Saxony
Research Site
Dresden
Research Site
Görlitz
Research Site
Halle, Saxony-Anhalt
Research Site
Hanover, Lower Saxony
Research Site
Hermaringen
Research Site
Leipzig
Research Site
Löbau
Research Site
Magdeburg
Research Site
Münster
Research Site
Saarbrücken, Saarland
Research Site
Stuttgart, Baden-Wurttemberg
Research Site
Weener
Research Site
Wolmirstedt
Canada16 sites
Research Site
Burlington, Ontario
Research Site
Calgary, Alberta
Research Site
Charlottetown, Prince Edward Island
Research Site
Edmonton, Alberta
Research Site
Etobicoke, Ontario
Research Site
Halifax, Nova Scotia
Research Site
Hamilton, Ontario
Research Site
Mount Pearl, Newfoundland and Labrador
Research Site
North York, Ontario
Research Site
Penticton, British Columbia
Research Site
Saint-Léonard, Quebec
Research Site
Saskatoon, Saskatchewan
Research Site
St. John's, Newfoundland and Labrador
Research Site
Toronto, Ontario
Research Site
Windsor, Ontario
Research Site
Winkler, Manitoba
Denmark14 sites
Research Site
Charlottenlund
Research Site
Elsinore
Research Site
Esbjerg
Research Site
Frederiksberg
Research Site
Frederikssund
Research Site
Herning
Research Site
Hillerød
Research Site
København K
Research Site
København NV
Research Site
Kolding
Research Site
Odense
Research Site
Odense C
Research Site
Randers
Research Site
Vejle
Netherlands14 sites
Research Site
's-Hertogenbosch
Research Site
Beek en Donk
Research Site
Deurne, North Brabant
Research Site
Hoogvliet, South Holland
Research Site
Hoogwoud
Research Site
Huizen
Research Site
Lichtenvoorde, Gelderland
Research Site
Nijverdal
Research Site
Oldebroek, Overijssel
Research Site
Rijswijk, South Holland
Research Site
Roelofarendsveen, South Holland
Research Site
Rotterdam, South Holland
Research Site
Spijkenisse
Research Site
Tilburg
Sweden8 sites
Research Site
Åkersberga
Research Site
Gothenburg
Research Site
Krokom
Research Site
Norrtälje
Research Site
Östersund
Research Site
Stockholm
Research Site
Trollhättan
Research Site
Umeå
Norway6 sites
Research Site
Bergen
Research Site
Gjøvik
Research Site
Hønefoss
Research Site
Nestun
Research Site
Oslo
Research Site
Skedsmokorset
About this study
Official title: A Randomized Double-Blind Placebo-Controlled Multi-Centre Pilot Study to Assess Symptom Response in Subjects With Pain or Discomfort in the Chest Receiving Oral Treatment With Esomeprazole 40 mg Bid for 4 Weeks.
The purpose of this study is to compare the efficacy of Nexium® with placebo in relief of acid related pain or discomfort in the chest.
- Conditions
- Chest Pain, Gastroesophageal Reflux
- Being tested
- Esomeprazole
- Keywords
- Gastroesophageal reflux disease, GERD
- Medical subject headings
- Chest Pain, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief of pain or discomfort in the chest during the last week of the 4-week treatment course.
Relief of pain or discomfort in the chest is defined as no more than one day with minimal symptoms according to the patients assessment
Secondary outcomes (4)
Symptom response during the first week is based on diary cards, days 3-7.
The investigator's overall assessment of pain or discomfort in the chest during the first and fourth week.
Scores from the PRO instruments measuring pain, HRQL, anxiety and depression, health status, reflux related symptoms and overall treatment evaluation.
Adverse events, clinical laboratory variables and vital signs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2005 (estimated)
- Study startMay 2004
- Primary completionJul 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Nexium Medical Sciences Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251901
- Sponsor's protocol ID
- D9914C00001
- Status last verified
- Jan 2011
- First submitted
- 9 Nov 2005
- Last updated
- 24 Jan 2011
- Results posted
- No
Publications
Wade D, Cooper J, Derry F, Taylor J. Uro-Vaxom(R) versus placebo for the prevention of recurrent symptomatic urinary tract infections in participants with chronic neurogenic bladder dysfunction: a randomised controlled feasibility study. Trials. 2019 Apr 16;20(1):223. doi: 10.1186/s13063-019-3275-x.
PubMed 30992071Flook NW, Moayyedi P, Dent J, Talley NJ, Persson T, Karlson BW, Ruth M. Acid-suppressive therapy with esomeprazole for relief of unexplained chest pain in primary care: a randomized, double-blind, placebo-controlled trial. Am J Gastroenterol. 2013 Jan;108(1):56-64. doi: 10.1038/ajg.2012.369. Epub 2012 Nov 13.
PubMed 23147520
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Placebo-Controlled Multi-Centre Pilot Study to Assess Symptom Response in Subjects With Pain or Discomfort in the Chest Receiving Oral Treatment With Esomeprazole 40 mg Bid for 4 Weeks.
- ClinicalTrials.gov ID
- NCT00251901
- Acronym / sponsor ID
- D9914C00001
- Conditions
- Chest Pain, Gastroesophageal Reflux
- Keywords
- Gastroesophageal reflux disease, GERD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 11 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy of Nexium® with placebo in relief of acid related pain or discomfort in the chest.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pain or discomfort in the chest without any identifiable cause and severe enough for the patient to seek primary medical or similar care.
- History of pain or discomfort in the chest for at least the last two weeks prior to enrollment.
Key exclusion criteria (2 listed)
- Signs, symptoms or relevant investigations suggestion present symptomatic coronary heart disease.
- Patients whose pain or discomfort in the chest warrants urgent cardiac investigation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esomeprazole | Drug | – |
Primary outcome
Relief of pain or discomfort in the chest during the last week of the 4-week treatment course.
Relief of pain or discomfort in the chest is defined as no more than one day with minimal symptoms according to the patients assessment
4 secondary outcomes
Symptom response during the first week is based on diary cards, days 3-7.
The investigator's overall assessment of pain or discomfort in the chest during the first and fourth week.
Scores from the PRO instruments measuring pain, HRQL, anxiety and depression, health status, reflux related symptoms and overall treatment evaluation.
Adverse events, clinical laboratory variables and vital signs.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2011.
- Derived from this study: PubMed 30992071Wade D, Cooper J, Derry F, Taylor J. Uro-Vaxom(R) versus placebo for the prevention of recurrent symptomatic urinary tract infections in participants with chronic neurogenic bladder dysfunction: a randomised controlled feasibility study. Trials. 2019 Apr 16;20(1):223. doi: 10.1186/s13063-019-3275-x.
- Derived from this study: PubMed 23147520Flook NW, Moayyedi P, Dent J, Talley NJ, Persson T, Karlson BW, Ruth M. Acid-suppressive therapy with esomeprazole for relief of unexplained chest pain in primary care: a randomized, double-blind, placebo-controlled trial. Am J Gastroenterol. 2013 Jan;108(1):56-64. doi: 10.1038/ajg.2012.369. Epub 2012 Nov 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AstraZeneca Nexium Medical Sciences Director, MD study director
AstraZeneca
80 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Esomeprazole in people with Chest Pain and Gastroesophageal Reflux, run by AstraZeneca at 80 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 80 sites in Germany, Canada, Denmark, Netherlands, Sweden and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relief of pain or discomfort in the chest during the last week of the 4-week treatment course.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00251901, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2011.